FDA 510(k)

Stryker 通用神经 III 系统AXS 螺钉

K号: K171152 · 2017-05-19

决定日期2017-05-19

产品代码HBW

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决定实质等同

器械摘要

Stryker Universal Neuro III System AXS Screw is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2017-05-19 under 510(k) number K171152. The device is classified under product code HBW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Stryker Universal Neuro III System AXS Screw?

Stryker Universal Neuro III System AXS Screw is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is Stryker. The 510(k) number is K171152.

When did Stryker Universal Neuro III System AXS Screw receive FDA 510(k) clearance?

Stryker Universal Neuro III System AXS Screw received FDA 510(k) clearance on 2017-05-19, under 510(k) number K171152.

Who is the listed applicant for Stryker Universal Neuro III System AXS Screw?

The FDA 510(k) record lists Stryker as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stryker Universal Neuro III System AXS Screw?

The FDA product code for Stryker Universal Neuro III System AXS Screw is HBW.

列明Stryker为申报人的其他记录

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